Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Drawings
The drawings are objected to because Figure 6 lacks labeled axes and therefore it is unclear what is being represented in the drawing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 19 follows.
STEP 1
Regarding Claim 19, the claim recites a method configured to generate temperature and impedance values proximate to an implantation site of a medical device and determine if these values are indicators of infection. Thus, this claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
This claim is then analyzed to determine whether it is directed to any judicial exception. The first step of determining whether a first one or more infection criteria are satisfied by temperature data and impedance data wherein the first one or more infection criteria include at least one criterion indicative of decreased impedance and the second step of determining whether a second one or more infection criteria are satisfied by the temperature data and impedance data wherein the second one or more infection criteria include at least one criterion indicative of increased impedance both set forth a judicial exception. These steps describe a concept performed in the human mind or by use of pen and paper (including an observation, evaluation, judgment, opinion). Thus, this claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 19 recites outputting an indication of infection, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The outputting an indication of infection does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the output, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 19 includes outputting indication of infection, which as discussed above, is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding Claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited “an implantable medical device” is a generically claimed device configured to perform insignificant routine pre-solution data gathering activity. The recited “processing circuitry” is a computer configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The same rationale that applies to Claim 1 applies to Claim 20.
The rest of the dependent claims fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and determining steps that can be performed by mentally comparing data to criteria. Regarding Claim 3, the time interval of “at least three days” is not deemed critical as improvement to an Abstract Idea is still an Abstract Idea. Regarding Claim 6, the determining limitations are pre-solution data gathering functions performed by a mental process. Regarding Claims 9, 13, and 15, the determining moving averages limitations are pre-solution data gathering functions performed by mathematical concepts. Regarding Claim 16, the additional element of “a motion sensor” that determines a patient’s posture and/or activity level in order to discard a portion of the temperature and/or impedance data based on their posture/activity is a generic device that amounts to nothing more than pre-solution activity of mere data gathering.
The generating, determining, and outputting steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. A computer-readable storage medium can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that applicant amend the claims to recite a “non-transitory computer-readable storage medium” in order to recite statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-8, 10-12, 14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et. al.’322 (U.S. Patent Publication 20080262322 – previously cited) in view of Joseph et. al.’238 (U.S. Patent Publication 20130041238 – previously cited).
Regarding Claim 1, Gerber et. al.’322 discloses a system comprising an implantable medical device configured to generate temperature data and impedance data associated with temperature and impedance of a patient proximate to the implantable medical device (Paragraph [0029] - The systems, devices and methods determine whether an infection is in proximity to the implantable medical device by using more than one metric associated with a monitored indicator of infection; Paragraph [0038] - Changes in temperature in proximity to implanted device 1 may be used as an indicator of infection in proximity to device; Paragraph [0039] - Changes in impedance of tissue in proximity to implanted device 1 may be used as an indicator of infection in proximity to device), and
processing circuitry (Paragraph [0037] - Sensor 50, 50' may be any device capable of detecting and transmitting information regarding an indicator of infection to device 1 or capable of detecting and transmitting information that may be useful in determining whether an indicator of infection may actually be indicative of infection) configured to:
determine whether a first one or more infection criteria are satisfied by temperature data and impedance data generated by the implantable medical device during a first time interval, wherein the first one or more infection criteria include at least one criterion indicative of decreased impedance, wherein the at least one criterion indicative of decreased impedance is satisfied based on at least some of the impedance data generated during the first time interval being less than baseline impedance data generated by the implantable medical device before the first time interval (Paragraph [0008] - determining whether the indicator crosses a first threshold indicative of infection for a first period of time; Paragraph [0039] - a decrease in impedance of tissue in proximity may serve as an indicator of infection). The examiner has noted that Gerber’322 recites “threshold” in a similar way that the instant applicant uses “infection criteria”.
Gerber et. al.’322 also discloses an output, based on satisfaction of the first and second infection criteria, an indication of infection (Paragraph [0008] - and issuing a first alert if the indicator crosses the first threshold for the first period of time…issuing a second alert if the indicator crosses the second threshold for the second period of time. The first and second alert may be the same or different; Paragraph [0046] - one or more second indicators of infection may be used to determine whether the indication based on the first indicator is accurate).
Gerber et. al.’322 discloses a processing circuitry that is also configured to: determine whether a second one or more infection criteria are satisfied by the temperature data and impedance data generated by the implantable medical device during a second time interval subsequent to the first time interval, wherein the second one or more infection criteria include at least one criterion indicative of increased impedance (Paragraph [0008] - determining whether the indicator crosses a second threshold indicative of infection for a second period of time; Paragraph [0039] - failure to detect an increase in impedance over a period of time following implantation may serve as an indication of infection) but fails to disclose wherein the at least one criterion indicative of increased impedance is satisfied based on at least some of the impedance data generated during the second time interval being greater than the baseline impedance data generated by the implantable medical device before the first time interval. Joseph et. al.’238 teaches indicating an infection based on increased impedance during a second time interval wherein the impedance is greater during the second time interval than a previous measurement (Paragraph [0022] - The method can involve impedance measurement across the electrodes using Electrical Impedance Spectroscopy (EIS) or an alternative technique to measure impedance, as statistically significant increases in impedance across the electrodes are indicative of the formation of a biofilm; Paragraph [0085] - Generally an increase in impedance of more than 50% noted in at least two consecutive measurements is indicative of the presence of or formation of a biofilm; Paragraph [0094] - the implant surfaces are at risk for infection with biofilm microorganisms). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Gerber et. al.’322 to include consideration of an increase in impedance being an indicator for infection due to the effect that microbial biofilm has on increasing impedance after a certain amount of time post implantation as seen in Joseph et. al.’238 (Paragraph [0004] - biofilm formation on medical implants is therefore extremely problematic... microorganisms can attach to and develop biofilms on any type of medical implant, whether temporarily or permanently inserted or implanted in a patient's body, and can be a source of chronic bacterial infections. Chronic infections that are caused by biofilms on a medical implant (e.g., otitis media and osteomyelitis) often result in treatment failure and reoccurrence shortly after treatment. In 2005, biofilms accounted for about 65% of infections treated in the developed world).
The same rejections for Claim 1 hold for Claims 19 and 20 with the addition that Gerber et. al.’322 discloses a computer-readable medium in regards to Claim 20 (Paragraph [0068] - a computer readable medium containing instructions that when implemented cause an implantable medical device (or system including an implantable medical device) to perform the methods described herein).
Regarding Claim 2, Gerber et. al.’322 discloses the system wherein the processing circuitry is configured to determine whether the one or more second infection criteria are satisfied in response to satisfaction of the one or more first infection criteria (Paragraph [0046] - one or more second indicators of infection may be used to determine whether the indication based on the first indicator is accurate).
Regarding Claim 4, Gerber et. al.’322 discloses the system to determine whether the first one or more infection criteria are satisfied, the processing circuitry is configured to determine a maximum temperature during the first time interval (Paragraph [0056] - the first threshold determination (510) may be whether a temperature of 103.degree. F. (3.94 C) or greater has been detected at a given point in time).
Regarding Claim 5, Gerber et. al.’322 discloses the system to determine whether the at least one criterion indicative of decreased impedance is satisfied, the processing circuitry is configured to determine a minimum impedance during the first time interval (Paragraph [0064] - For impedance, the first threshold may be, for example, a 30% deviation from a mean value at a point in time).
Regarding Claim 6, Gerber et. al.’322 discloses the system to determine whether the first one or more infection criteria are satisfied, the processing circuitry is configured to: determine a maximum temperature during the first time interval (Paragraph [0056] - the first threshold determination (510) may be whether a temperature of 103.degree. F. (3.94 C) or greater has been detected at a given point in time),
determine a minimum impedance during the first time interval (Paragraph [0064] - For impedance, the first threshold may be, for example, a 30% deviation from a mean value at a point in time), and
determine a difference between a time of the maximum temperature and a time of the minimum impedance (Paragraph [0056] - with the first threshold determination, the second threshold determination may include determining whether a value has been detected over consecutive discrete readings, continuously over time, etc. With the first or second determinations (510, 530), the determination may include whether a threshold value has been crossed over a percentage of the period of time).
Regarding Claim 7, Gerber et. al.’322 discloses the system to determine whether the first one or more infection criteria are satisfied, the processing circuitry is configured to: determine a first indicator value based on one or more of the maximum temperature, the minimum impedance, or the difference between the time of the maximum temperature and the time of the minimum impedance (Paragraph [0056] - the first threshold determination (510) may be whether a temperature of 103.degree. F. (3.94 C) or greater has been detected at a given point in time),
determine a second indicator value based on the comparison of the impedance data generated during the first time interval to the baseline impedance data (Paragraph [0056] - Processor 110 may determine whether the first threshold is crossed for the first period of time by comparing an indicator metric 200 stored in memory 120 with a first threshold value 210; Paragraph [0058] - an indicator of infection is monitored (500). The monitoring may occur over discrete time intervals. As with the embodiments depicted in FIGS. 8A-B, a determination is made as to whether the monitored indicator crosses a first threshold (510) and may include determining whether the monitored indicator crosses a second threshold (530); Figures 8A-9), and
determine an infection likelihood value based on application of a first weightage to the first indicator value and a second weightage to the second indicator value, wherein the first weightage is greater than the second weightage (Paragraph [0056] - a value associated with the second threshold 220 is less indicative a comparable value associated with the first threshold 210).
The examiner has noted that Gerber et. al.’322 has referred to “indicator metric” in a similar manner that the instant application refers to “baseline data”.
Regarding Claim 8, Gerber et. al.’322 discloses the system to determine whether the at least one criterion indicative of decreased impedance is satisfied, the processing circuitry is configured to compare the impedance data generated during the first time interval to baseline impedance data generated by the implantable medical device prior to the first time interval (Paragraph [0056] - Processor 110 may determine whether the first threshold is crossed for the first period of time by comparing an indicator metric 200 stored in memory 120 with a first threshold value 210).
Regarding Claim 10, Gerber et. al.’322 discloses the system to determine whether the second one or more infection criteria are satisfied, the processing circuitry is configured to determine whether a peak occurs in the temperature data generated during the second time interval (Paragraph [0062] - The second threshold may be greater than or equal to 100.degree. F. (37.8 C) over two hours).
Regarding Claim 11, Gerber et. al.’322 discloses the system to determine whether the second one or more infection criteria are satisfied, the processing circuitry is configured to: determine a first indicator value based on one or more of a comparison of the temperature data generated during the second time interval to a baseline temperature data or a comparison of the impedance data generated during the second time interval to the baseline impedance data (Paragraph [0056] - Processor 110 may determine whether the first threshold is crossed for the first period of time by comparing an indicator metric 200 stored in memory 120 with a first threshold value 210; Paragraph [0058] - an indicator of infection is monitored (500). The monitoring may occur over discrete time intervals. As with the embodiments depicted in FIGS. 8A-B, a determination is made as to whether the monitored indicator crosses a first threshold (510) and may include determining whether the monitored indicator crosses a second threshold (530); Figures 8A-9),
determine a second indicator value based on the peak in the temperature data generated during the second time interval (Paragraph [0062] - The second threshold may be greater than or equal to 100.degree. F. (37.8 C) over two hours), and
determine an infection likelihood value based on application of a first weightage to the first indicator value and a second weightage to the second indicator value, wherein the first weightage is greater than the second weightage (Paragraph [0048] - a value associated with the second threshold 220 is less indicative a comparable value associated with the first threshold 210).
Regarding Claim 12, Gerber et. al.’322 discloses the system to determine whether the second one or more infection criteria are satisfied, the processing circuitry is configured to compare the temperature data generated during the second time interval to baseline temperature data generated by the implantable medical device before the first time interval (Paragraph [0056] - Processor 110 may determine whether the first threshold is crossed for the first period of time by comparing an indicator metric 200 stored in memory 120 with a first threshold value 210; Paragraph [0058] - an indicator of infection is monitored (500). The monitoring may occur over discrete time intervals. As with the embodiments depicted in FIGS. 8A-B, a determination is made as to whether the monitored indicator crosses a first threshold (510) and may include determining whether the monitored indicator crosses a second threshold (530); Figures 8A-9).
Regarding Claim 14, Gerber et. al.’322 discloses the system to determine whether the at least one criterion indicative of increased impedance is satisfied, the processing circuitry is configured to compare the impedance data generated during the second time interval to baseline impedance data generated by the implantable medical device before the first time interval (Paragraph [0056] - Processor 110 may determine whether the first threshold is crossed for the first period of time by comparing an indicator metric 200 stored in memory 120 with a first threshold value 210; Paragraph [0058] - an indicator of infection is monitored (500). The monitoring may occur over discrete time intervals. As with the embodiments depicted in FIGS. 8A-B, a determination is made as to whether the monitored indicator crosses a first threshold (510) and may include determining whether the monitored indicator crosses a second threshold (530); Figures 8A-9).
Regarding Claim 17, Gerber et. al.’322 discloses the system wherein the indication of infection is an indication of pocket infection (Paragraph [0029] - the systems, devices and methods determine whether an infection is in proximity to the implantable medical device).
Regarding Claim 18, Gerber et. al.’322 discloses the system wherein the processing circuitry comprises processing circuitry of the implantable medical device (Paragraph [0037] - Sensor 50, 50' may be any device capable of detecting and transmitting information regarding an indicator of infection to device 1 or capable of detecting and transmitting information that may be useful in determining whether an indicator of infection may actually be indicative of infection).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber et. al.’322 (U.S. Patent Publication 20080262322 – previously cited) in view of Joseph et. al.’238 (U.S. Patent Publication 20130041238 – previously cited) as applied to Claim 1 above.
Regarding Claim 3, Gerber et. al.’322 in view of Joseph et. al.’238 discloses the system outlined in Claim 1 above. Gerber et. al.’322 also discloses wherein an endpoint of the second period of time for identifying indicators of infection is longer than an endpoint of the first period of time (Paragraph [0056] - indicator crosses a second threshold for a second period of time (530), which is longer than the first period of time associated with the first threshold), but fails to explicitly disclose the system wherein the second time interval extends at least three days later than the first time interval. It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the “3 days” time period. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal timeframe for tracking possible indicators of infection. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to “discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 9, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et. al.’322 (U.S. Patent Publication 20080262322 – previously cited) in view of Joseph et. al.’238 (U.S. Patent Publication 20130041238 – previously cited), as applied to Claim 12, in view of Bjorling et. al.’472 (U.S. Patent Publication 20110166472).
Regarding Claim 9, Gerber et. al.’322 in view of Joseph et. al.’238 discloses the system outlined in Claim 8. Gerber et. al.’322 further discloses comparing measured impedance data to average impedance data across different time period (Paragraph [0054] - processor 110 may compare indicator metric 200 to a mean or median indicator value 200 determined over time to determine whether a threshold has been crossed; Paragraph [0064] - a 25% deviation from a mean value over a twelve hour time period, etc.), but fails to disclose circuitry configured to determine a short-term moving average of impedance data generated by the implantable medical device comprising the impedance data generated during the first time interval; determine a long-term moving average of impedance data generated by the implantable medical device comprising the baseline impedance data; and accumulate differences between the short-term moving average and the long-term moving average. Bjorling et. al.’472 teaches determining a difference between short-term and long-term moving averages of impedance data across different points in time (Paragraph [0071] - z_short(i)=short term average at sample I; Paragraph [0077] - the long average is compared to the short average; Paragraph [0078] - the short moving average is lower than the long moving average (i.e. the impedance is dropping or decreasing) wherein the long-term moving average comprises a reference – baseline - impedance trend (Paragraph [0009] - A reference value or impedance is established as the average over a period of three days. This reference impedance is adapted over time to the measured impedances, increasing or decreasing daily by a small amount in order to approximate the patients' long-term impedance trend; Paragraph [0072] - z_ref=reference value=long term average at sample i). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Gerber et. al.’322 in view of Joseph et. al.’238 to include comparing short-term and long-term moving averages across different measurement times of physiological measurements in order to establish threshold criteria indicative of physiological measurement trends and identify when physiological parameters such as impedance are increasing or decreasing beyond a threshold amount as seen in Bjorling et. al.’472.
Regarding Claim 13, Gerber et. al.’322 in view of Joseph et. al.’238 discloses the system outlined in Claim 12 above. Gerber et. al.’322 further discloses comparing measured physiological data, such as temperature, to average impedance data across different time period (Paragraph [0045] - elevation in temperature in proximity to device 1 may be due to localized infection or may be due to increased activity of the patient; Paragraph [0054] - processor 110 may compare indicator metric 200 to a mean or median indicator value 200 determined over time to determine whether a threshold has been crossed), but fails to disclose circuitry configured to determine a short-term moving average of temperature data generated by the implantable medical device comprising temperature data generated during the second time interval; determine a long-term moving average of temperature data generated by the implantable medical device comprising the baseline temperature data; and accumulate differences between the short-term moving average and the long-term moving average. Bjorling et. al.’472 teaches determining a difference between short-term and long-term moving averages of physiological data across different points in time (Paragraph [0071] - z_short(i)=short term average at sample I; Paragraph [0077] - the long average is compared to the short average; Paragraph [0078] - the short moving average is lower than the long moving average (i.e. the impedance is dropping or decreasing) wherein the long-term moving average comprises a reference – baseline - impedance trend (Paragraph [0009] - A reference value or impedance is established as the average over a period of three days. This reference impedance is adapted over time to the measured impedances, increasing or decreasing daily by a small amount in order to approximate the patients' long-term impedance trend; Paragraph [0072] - z_ref=reference value=long term average at sample i). Although Bjorling et. al.’472 does not explicitly disclose comparing “temperature” based data between short-term and long-term moving averages, one of ordinary skill in the art would find it obvious that methods used to compare one type of physiological data such as impedance can be applied to other forms of physiological data such as temperature. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Gerber et. al.’322 in view of Joseph et. al.’238 to include comparing short-term and long-term moving averages across different measurement times of physiological measurements in order to establish threshold criteria indicative of physiological measurement trends and identify when physiological parameters are increasing or decreasing beyond a threshold amount as seen in Bjorling et. al.’472.
Regarding Claim 15, Gerber et. al.’322 in view of Joseph et. al.’238 discloses the system outlined in Claim 14. Gerber et. al.’322 further discloses comparing measured impedance data to average impedance data across different time period (Paragraph [0054] - processor 110 may compare indicator metric 200 to a mean or median indicator value 200 determined over time to determine whether a threshold has been crossed; Paragraph [0064] - a 25% deviation from a mean value over a twelve hour time period, etc.), but fails to disclose circuitry configured to determine a short-term moving average of impedance data generated by the implantable medical device comprising the impedance data generated during the second time interval; determine a long-term moving average of impedance data generated by the implantable medical device comprising the baseline impedance data; and accumulate differences between the short-term moving average and the long-term moving average. Bjorling et. al.’472 teaches determining a difference between short-term and long-term moving averages of impedance data across different points in time (Paragraph [0071] - z_short(i)=short term average at sample I; Paragraph [0077] - the long average is compared to the short average and if the short moving average is above the long moving average (i.e. the impedance is increasing) wherein the long-term moving average comprises a reference – baseline - impedance trend (Paragraph [0009] - A reference value or impedance is established as the average over a period of three days. This reference impedance is adapted over time to the measured impedances, increasing or decreasing daily by a small amount in order to approximate the patients' long-term impedance trend; Paragraph [0072] - z_ref=reference value=long term average at sample i). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Gerber et. al.’322 in view of Joseph et. al.’238 to include comparing short-term and long-term moving averages across different measurement times of physiological measurements in order to establish threshold criteria indicative of physiological measurement trends and identify when physiological parameters such as impedance are increasing or decreasing beyond a threshold amount as seen in Bjorling et. al.’472.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber et. al.’322 (U.S. Patent Publication 20080262322 – previously cited) in view of Joseph et. al.’238 (U.S. Patent Publication 20130041238 – previously cited), as applied to Claim 1, in view of Kim et. al.’675 (U.S. Patent Publication 20130053675 – previously cited).
Regarding Claim 16, Gerber et. al.’322 in view of Joseph et. al.’238 discloses the system outlined in Claim 1 above but fails to disclose the system comprising a motion sensor, wherein the processing circuitry is configured to: determine at least one of an activity level or posture of the patient based on a signal from the motion sensor and discard at least a portion of at least one of the temperature data or the impedance data based on the activity level or posture. Kim et. al.’675 teaches removing physiological signal data that includes motion artifact in order to obtain a physiological signal free from motion artifact (Paragraph [0051] - the bioelectric signal measurement apparatus 100 measures a signal proportional to the motion artifact separate from a bioelectric signal including the motion artifact, and removes the signal from the bioelectric signal including the motion artifact using the signal proportional to the motion artifact, thereby obtaining a bioelectric signal free of the motion artifact).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the processing circuitry of Gerber et. al.’322 in view of Joseph et. al.’238 to be configured to determine an activity level based on a signal from a motion sensor and to discard at least a portion of at least one of the temperature data or the impedance data based on the activity level, as this would result in more accurate temperature or impedance data free from motion-induced artifacts.
Response to Arguments
Applicant's arguments filed 10 March 2026 have been fully considered and they are not entirely persuasive.
The examiner has made note of a drawing objection based on Figure 6 and addressed this issue in Paragraph 3 above.
Regarding the rejection under 35 U.S.C. 101, the examiner notes that processors are a generic device and determining criteria being indicative of impedance values are drawn to a mental process. Additionally, the applicant is arguing that there is inventive nature in the critical time interval of "at least 3 days" as recited in Claim 3 based on Figure 6. However, the criticality of this time period is not specified within the applicant's description and Figure 6 is vague given the lack of labels/units. Paragraph [0063] of the instant application’s specification recites the following: "Time interval 210 may extend or include data generated at least three days after time interval 208...Temperature data 202 and impedance data 204 may exhibit a sustained rise after the initial infection, e.g., three to six days after the initial infection, such as during time interval 210". Therefore, “at least three days” is a wider range that is not supported in the instant application given that this verbiage “at least three days” could encompass more than 6 days. Furthermore, the examiner has made note of an additional rejection under 35 U.S.C. 101 for Claim 20 due to claiming non-statutory subject matter. The rejections under 35 U.S.C. 101 are further addressed in Paragraphs 4 and 5 above.
Regarding Claim 6, the examiner has found the arguments to be not persuasive. Gerber et. al.’322 discloses an impedance value that deviates from the average by a certain amount (Paragraph [0064] - For impedance, the first threshold may be, for example, a 30% deviation from a mean value at a point in time). This deviation is not limited to being “greater” than a mean value and therefore can be indicative of a “minimum impedance value”. Additionally, the current recitation of the claim limitation “determine a difference between a time of the maximum temperature and a time of the minimum impedance” is disclosed by Gerber et. al.’322. Gerber et. al.’322 discloses determining when readings are taken in accordance to one another based on when different physiological extreme measurement value readings are obtained (Paragraph [0056] - with the first threshold determination, the second threshold determination may include determining whether a value has been detected over consecutive discrete readings, continuously over time, etc. With the first or second determinations (510, 530), the determination may include whether a threshold value has been crossed over a percentage of the period of time). This comparison disclosed by Gerber et. al.’322 is indicative of a difference between obtained reading times.
Regarding Claims 9, 13, and 15, the examiner has found the arguments pertaining to the previous prior art of record Braganza et. al.’160 to be persuasive regarding the filing date. The examiner has cited new prior art pertaining to these claims as addressed in Paragraph 8 above.
Regarding the applicant’s argument pertaining to the "subsequent measurements" language, the examiner has found these arguments to be not persuasive. Gerber et. al.’322 discloses that a first time period and threshold are determined followed by a second time period and threshold (Paragraph [0056] - If the indicator does not cross the first threshold, a determination is made as to whether the indicator crosses a second threshold for a second period of time (530), which is longer than the first period of time associated with the first threshold. As with the first threshold determination, the second threshold determination may include determining whether a value has been detected over consecutive discrete readings, continuously over time, etc. With the first or second determinations (510, 530), the determination may include whether a threshold value has been crossed over a percentage of the period of time; Figures 8A-9).
Regarding the applicant’s arguments pertaining to increasing and decreasing impedance, the examiner has found these arguments to be not persuasive. Gerber directly discloses decreasing impedance in Paragraph [0008] as well as Paragraph [0039] that states a "decrease in impedance of tissue in proximity may serve as an indicator of infection". Gerber et. al.'322 further discloses a second indication of infection that is different from the first (Paragraph [0046] - In addition, one or more second indicators of infection may be used to determine whether the indication based on the first indicator is accurate) and wherein a second indicator could include bacterial proteins (Paragraph [0042]). Joseph et. al.'238 teaches a sign of infection could be bacterial protein, or biofilm biomarker. Joseph et. al.'238 further teaches that biofilm formation leads to an increased impedance. In combination, Gerber et. al.’322 in view of Joseph et. al.’238 would teach increasing and decreasing impedance parameters representative of infection.
Claims 1-20 are rejected under 35 U.S.C. 103 as addressed in Paragraphs 6-9 above.
Conclusion
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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